FDA 510(k) Application Details - K854718

Device Classification Name Bromcresol Green Dye-Binding, Albumin

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510(K) Number K854718
Device Name Bromcresol Green Dye-Binding, Albumin
Applicant NOBEL SCIENTIFIC INDUSTRIES, INC.
1423 LESLIE AVE.
ALEXANDRIA, VA US
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Contact DONALD F DWYER
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Regulation Number 862.1035

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Classification Product Code CIX
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Date Received 11/22/1985
Decision Date 12/19/1985
Decision SE - Substantially Equivalent
Classification Advisory Committee CH - Clinical Chemistry
Review Advisory Committee CH - Clinical Chemistry
Statement / Summary / Purged Status
Type Traditional
Reviewed By Third Party N
Expedited Review



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